Glycopyrrolate inhaled/formoterol

Pregnancy

There are no adequate and well-controlled studies in humans with Bevespi Aerosphere or its individual components

Single-dose studies in humans found that a very small amount of glycopyrrolate passed the placental barrier

Animal studies

• Glycopyrrolate
  • There was no evidence of teratogenic effects in rats and rabbits at approximately 18,000 and 270 times, respectively, the maximum recommended human daily inhalation dose (MRHDID) in adults
• Formoterol fumarate
  • Formoterol fumarate has been shown to be teratogenic, to be embryocidal, to increase pup loss at birth and during lactation, and to decrease pup weights in rats and teratogenic in rabbits
  • These effects were observed at approximately 1,500 (rats) and 61,000 (rabbits) times the MRHDID
  • Other observations in animal studies included umbilical hernia, prolonged pregnancy, fetal brachygnathia, and liver cysts

Lactation

Unknown if distributed in human breast milk

Since there are no data from controlled trials by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of drug treatment to the mother

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.